NCT01882712撤回3 期
Phase 3 Efficacy and Safety Study of CD07805/47 Topical Gel in Subjects With Persistent Facial Erythema
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- Galderma R&D
- 主要终点
- Composite success on both CEA (Clinician Erythema Assessment ) and PSA (Patient Self Assessment)
研究概览
简要总结
The purpose of this study is to compare the efficacy and assess the safety of CD07805/47 gel 0.5% applied topically once daily for 29 days versus vehicle control, in subjects with moderate to severe chronic persistent vascular facial erythema
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, who is at least 18 years of age or older at screening visit.
- •Presence of chronic persistent vascular facial erythema for ≥ 3 months by history.
- •A Clinician's Erythema Assessment (CEA) score of ≥3 at Screening and at Pre-dose (T0) on Baseline/Day
- •A Patient Self Assessment (PSA) score of ≥3 at Screening and at Pre-dose (T0) on Baseline/Day 1.
排除标准
- •More than 2 facial inflammatory lesions (papules, pustules, and nodules).
- •Presence of areas of significant scaling or crusting on the face.
- •Presence of psoriatic lesions on the face.
- •Presence of any other dermatological condition of the face that, in the opinion of the Investigator, may significantly interfere with the interpretation of the clinical trial results.
研究组 & 干预措施
CD07805/47 Gel 0.5%
Experimental
active arm
干预措施: CD07805/47 Gel 0.5% (Drug)
CD07805/47 Gel Placebo
Placebo Comparator
Comparator arm
干预措施: CD07805/47 Gel Placebo (Drug)
结局指标
主要结局
Composite success on both CEA (Clinician Erythema Assessment ) and PSA (Patient Self Assessment)
时间窗: Day 29
2-grade improvement on both CEA and PSA at Hours 3, and 6 after Pre-dose (T0)on Day 29
次要结局
- Composite improvement on both CEA (Clinician Erythema Assessment ) and PSA (Patient Self Assessment)(Day 1)
研究者
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